Bioinformatics Modernization and the Critical Path to Improved Benefit-Risk Assessment of Drugs

Abstract

At FDA, bioinformatics means the design, development, and use of modem computer systems to efficiently and effectively manage the regulatory product information supply chain, along which medical product information travels among many relevant organizations. The FDA relies on efficient management of this information to assess a drug's safety and effectiveness. The current bioinformatics infrastructure that supports product information exchange is inefficient and is comparable to the antiquated infrastructure of the financial industry inyears past. Bioinformatics modernization requires improvements in three important information management domains: access, standards, and interface. We must have better access to information, more standardized information, and better interface with information (ie, better tools to convert information into knowledge). The FDA has taken measurable steps to modernize its bioinformatics infrastructure, but the effort is costly, complex, and time consuming. Nonetheless, it is a necessary step to improve the Critical Path and enhance benefit-risk assessments of drugs.